5 steps to running QC

1. Guide to Running QCGuide to Running QC
QUALITY CONTROL
Receipt and Storage
• Upon receipt of the kits ensure the product
hasn’t been tampered with and that all vials
appear intact.
• Store all materials as per the recommendations
stated in the IFU provided.
1 Unopened vials of a liquid stable quality control should
be stored at 2o
C to 8o
C and will be stable until the expiry
date stated on the vial. Liquid frozen controls are normally
stored at -20o
C and lyophilised controls at 2o
C to 8o
C.
Safe Handling
• Wear appropriate Personal Protective
Equipment (PPE) before handling samples
and ensure your working environment is clean.
• Quality control samples should be handled in
the same manner as a patient sample.
2
Preparation
• Liquid Ready-to-Use -
No further preparation
is required.3
Proceed to step 4
Preparation
• Liquid Frozen - Allow the sample to
completely thaw at room temperature
before proceeding to step 4.
Once thawed ensure the
contents are thoroughly mixed
by rolling for 30 minutes.
Liquid frozen controls should
not be re-frozen.
Preparation
• Lyophilised - Bring the material to room temperature and carefully reconstitute
the contents with the required volume of distilled water and leave to roll for
30 minutes (refer to the IFU for volumes) before proceeding to step 4.
When reconstituting always use a pipette for accuracy.
It is a good idea to label the vial with the date of
reconstitution to avoid the use of expired material.
To extend the stability lyophilised controls can be divided
into aliquots of at least 0.3ml and stored at -20o
C to -70o
C
(refer to the IFU for stability claims).
Application
• Open the vial/aliquot carefully and
run the sample as you would a
patient sample on your laboratory’s
analyser (refer to individual
analysers for application).
• Refrigerate any unused material at
2o
C to 8o
C (prior to reuse mix the
contents thoroughly).
4
Always check the stability
limitations of the control and
ensure the control material is not
used outside these
recommendations.
The control volume used will be
the same as the serum volume
listed in the reagent kit insert.
Obtaining QC results & Data Interpretation
• Some analysers can be programmed for data
interpretation and acceptance of QC results.
• When interpreting QC data you should employ the
target values provided on the QC kit insert for your
instrument or method.
• Ensure the Lot Number, Expiry Date and Level (1,2
or 3) matches the kit insert you are using.
5 The control values obtained should fall within the ranges
provided on the kit insert. If the values do not fall within the
ranges provided stop patient testing and troubleshoot to
establish a root cause and implement corrective actions
An interlaboratory data management programme like
Acusera 24•7 will help to interpret QC data.
Randox Laboratories Ltd, 55 Diamond Road, Crumlin, County Antrim, United Kingdom, BT29 4QY
+44 (0) 28 9442 2413 +44 (0) 28 9445 2912 marketing@randox.com randoxqc.comQUALITY CONTROL
Information correct at time of print. Randox Laboratories Ltd is a subsidiary of Randox Holdings Limited a company registered within Northern Ireland with company number N.I. 614690. VAT Registered Number: GB 151 6827 08.
Product availability may vary from country to country. Please contact your local Randox representative for information. Products may be for Research Use Only and not for use in diagnostic procedures in the USA.